CY1114499T1 - BIAS AVAILABLE SOLID DOSAGE FORMS - Google Patents

BIAS AVAILABLE SOLID DOSAGE FORMS

Info

Publication number
CY1114499T1
CY1114499T1 CY20131100902T CY131100902T CY1114499T1 CY 1114499 T1 CY1114499 T1 CY 1114499T1 CY 20131100902 T CY20131100902 T CY 20131100902T CY 131100902 T CY131100902 T CY 131100902T CY 1114499 T1 CY1114499 T1 CY 1114499T1
Authority
CY
Cyprus
Prior art keywords
dosage form
metaxalone
blade
rpm
stirred
Prior art date
Application number
CY20131100902T
Other languages
Greek (el)
Inventor
Spiridon Spireas
Original Assignee
Spiridon Spireas
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Spiridon Spireas filed Critical Spiridon Spireas
Publication of CY1114499T1 publication Critical patent/CY1114499T1/en

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/41—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
    • A61K31/42—Oxazoles
    • A61K31/421—1,3-Oxazoles, e.g. pemoline, trimethadione
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A61K47/38—Cellulose; Derivatives thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/2031—Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, polyethylene oxide, poloxamers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2059—Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2095—Tabletting processes; Dosage units made by direct compression of powders or specially processed granules, by eliminating solvents, by melt-extrusion, by injection molding, by 3D printing
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00—Drugs for skeletal disorders
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P21/00—Drugs for disorders of the muscular or neuromuscular system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P21/00—Drugs for disorders of the muscular or neuromuscular system
    • A61P21/02—Muscle relaxants, e.g. for tetanus or cramps

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Inorganic Chemistry (AREA)
  • Neurology (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Pain & Pain Management (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

Μια φαρμακευτική στερεή δοσολογική μορφή περιλαμβάνει μεταξαλόνη και τουλάχιστον ένα έκδοχο σκόνης, όπου η μεταξαλόνη αναμειγνύεται σε ξηρή κατάσταση με το τουλάχιστον ένα έκδοχο σκόνης· το μείγμα μεταξαλόνης/σκόνης στη συνέχεια διαβρέχεται και κοκκοποιείται με τουλάχιστον ένα φαρμακευτικώς αποδεκτό πτητικό υγρό· και το υγρό κοκκοποίημα στη συνέχεια ξηραίνεται, αλέθεται και κατόπιν αναμειγνύεται με άλλα έκδοχα σκόνης για να δώσει το τελικό μείγμα μεταξαλόνης/σκόνης το οποίο στη συνέχεια συμπιέζεται για να παραχθεί η φαρμακευτική στερεή δοσολογική μορφή, και όπου: (i) 13% κατά βάρος ή περισσότερο της εν λόγω μεταξαλόνης διαλύεται περίπου 30 λεπτά από τη στιγμή που η εν λόγω δοσολογική μορφή τοποθετηθεί σε ένα αιχμηρό γυάλινο δοχείο διάλυσης πληρωμένο με 1000 mL απιονισμένου νερού, διατηρούμενο στους 25°C και αναδευόμενο σε μια ταχύτητα πτερυγίου 100 rpm χρησιμοποιώντας μια USP Τύπου II (πτερυγίου) συσκευή· ή (ii) 28% κατά βάρος ή περισσότερο της εν λόγω μεταξαλόνης διαλύεται περίπου 30 λεπτά από τη στιγμή που η εν λόγω δοσολογική μορφή τοποθετηθεί σε ένα πρότυπο γυάλινο δοχείο διάλυσης πληρωμένο με 1000 mL απιονισμένου νερού, διατηρούμενο στους 35°C και αναδευόμενο σε μια ταχύτητα πτερυγίου 100 rpm χρησιμοποιώντας μια USP Τύπου II (πτερυγίου) συσκευή· ή (iii) 27% κατά βάρος ή περισσότερο της εν λόγω μεταξαλόνης διαλύεται περίπου 30 λεπτά από τη στιγμή που η εν λόγω δοσολογική μορφή τοποθετηθεί σε ένα αιχμηρό γυάλινο δοχείο διάλυσης πληρωμένο με 500 mL ενός υδατικού διαλύματος 0.1% κατά βάρος Λαυρυλοθειικού Νατρίου ανά όγκο νερού, διατηρούμενο στους 37°C και αναδευόμενο σε μια ταχύτητα πτερυγίου 50 rpm χρησιμοποιώντας μια USP Τύπου II (πτερυγίου) συσκευή.A pharmaceutical solid dosage form comprises metaxalone and at least one powder excipient, wherein the metaxalone is blended dry with at least one powder excipient; the metaxalone / powder mixture is then wetted and granulated with at least one pharmaceutically acceptable volatile liquid and the liquid; is then dried, ground and then mixed with other powdered excipients to give the final silk / powder mixture which is then compressed to produce the pharmaceutical composition. flowable dosage form, and wherein: (i) 13% by weight or more of said metaxalone dissolves about 30 minutes after said dosage form is placed in a sharp glass dialysis vessel filled with 1000 mL of deionized water, maintained at 25 ° C and stirred at a blade speed of 100 rpm using a USP Type II (blade) device; or (ii) 28% by weight or more of said metaxalone dissolves about 30 minutes after said dosage form is placed in a standard glass scrap bin quenched with 1000 mL of deionized water, maintained at 35 ° C and stirred at a blade speed of 100 rpm using a USP Type II (blade) device; or (iii) 27% by weight or more of said siloxane dissolves about 30 minutes from the when said dosage form is placed in a sharp glass dialysate filled with 500 mL of a 0.1% aqueous solution of sodium lauryl sulfate per volume of water, maintained at 37 ° C and stirred at a fin speed of 50 rpm using a Type II USP ( flap) const EVI.

CY20131100902T 2004-03-08 2013-10-15 BIAS AVAILABLE SOLID DOSAGE FORMS CY1114499T1 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US55125704P 2004-03-08 2004-03-08
EP09165833.6A EP2110124B1 (en) 2004-03-08 2005-03-08 Bioavailable Solid Dosage Forms of Metaxalone

Publications (1)

Publication Number Publication Date
CY1114499T1 true CY1114499T1 (en) 2016-10-05

Family

ID=34964783

Family Applications (1)

Application Number Title Priority Date Filing Date
CY20131100902T CY1114499T1 (en) 2004-03-08 2013-10-15 BIAS AVAILABLE SOLID DOSAGE FORMS

Country Status (11)

Country Link
US (7) US20050276844A1 (en)
EP (2) EP1755559A1 (en)
CN (2) CN1980642A (en)
AU (1) AU2005221659B2 (en)
CA (1) CA2563739C (en)
CY (1) CY1114499T1 (en)
DK (1) DK2110124T3 (en)
ES (1) ES2430849T3 (en)
MX (1) MXPA06010146A (en)
NZ (1) NZ588259A (en)
WO (1) WO2005087204A1 (en)

Families Citing this family (13)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
AU2003276688A1 (en) * 2002-09-02 2004-03-19 Sun Pharmaceutical Industries Limited Pharmaceutical composition of metaxalone with enhanced oral bioavailability
EP1965795A2 (en) * 2005-12-29 2008-09-10 Teva Pharmaceutical Industries Ltd. Metaxalone formulations and methods for the preparation thereof
US20120093928A1 (en) * 2007-08-09 2012-04-19 Ranbaxy Laboratories Limited Oral metaxalone compositions
WO2009085637A1 (en) * 2007-12-21 2009-07-09 Url Pharma, Inc. Amorphous metaxalone and amorphous dispersions thereof
EP2421530B1 (en) * 2009-04-24 2019-08-21 Iceutica Pty Ltd. Formulation of metaxalone
CN103932988A (en) 2009-04-24 2014-07-23 伊休蒂卡有限公司 Novel Formulation of Indomethacin
CN102232938B (en) * 2010-05-06 2014-06-11 杭州赛利药物研究所有限公司 Metaxalone capsule and preparation method thereof
KR20160039608A (en) * 2013-07-22 2016-04-11 아이슈티카 인코포레이티드 Formulation of metaxalone
US9526734B2 (en) 2014-06-09 2016-12-27 Iceutica Pty Ltd. Formulation of meloxicam
US11672781B2 (en) * 2018-05-07 2023-06-13 Prana Biosciences Inc Metaxalone formulations
CN109157527B (en) * 2018-07-25 2021-05-04 珠海润都制药股份有限公司 Irbesartan capsule and preparation method thereof
US11918559B2 (en) * 2019-06-25 2024-03-05 Primus Pharmceuticals, Inc. Reduced dose metaxalone formulations
US20200405693A1 (en) * 2019-06-25 2020-12-31 Primus Pharmaceuticals, Inc. Reduced dose metaxalone formulations

Family Cites Families (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4036957A (en) * 1975-11-18 1977-07-19 A. H. Robins Company, Inc. Phenoxy compounds in combinations to suppress gastric bleeding in aspirin therapy
US3993767A (en) * 1975-11-18 1976-11-23 A. H. Robins Company, Incorporated Compositions to suppress gastric bleeding in indomethacin and phenylbutazone therapy
JP3766468B2 (en) * 1996-04-18 2006-04-12 麒麟麦酒株式会社 Laser printing media
US6096337A (en) * 1996-06-10 2000-08-01 Spireas; Spiridon Liquisolid systems and methods of preparing same
US5800834A (en) * 1996-06-10 1998-09-01 Spireas; Spiridon Liquisolid systems and methods of preparing same
DE19930143C1 (en) * 1999-06-30 2001-07-12 Wincor Nixdorf Gmbh & Co Kg Device arrangement with an assembly held in a housing
US6407128B1 (en) 2001-12-03 2002-06-18 Elan Pharmaceuticals, Inc. Method for increasing the bioavailability of metaxalone
AU2003276688A1 (en) 2002-09-02 2004-03-19 Sun Pharmaceutical Industries Limited Pharmaceutical composition of metaxalone with enhanced oral bioavailability
ATE415946T1 (en) * 2003-08-08 2008-12-15 Elan Pharma Int Ltd NEW METAXALONE COMPOSITIONS

Also Published As

Publication number Publication date
WO2005087204A1 (en) 2005-09-22
US20130245082A1 (en) 2013-09-19
CA2563739A1 (en) 2005-09-22
US20150352080A1 (en) 2015-12-10
CN103284965A (en) 2013-09-11
EP2110124B1 (en) 2013-07-17
US20160158203A1 (en) 2016-06-09
US20110124694A1 (en) 2011-05-26
ES2430849T3 (en) 2013-11-22
MXPA06010146A (en) 2007-05-11
US20100099723A1 (en) 2010-04-22
AU2005221659B2 (en) 2008-07-03
CA2563739C (en) 2013-07-09
CN1980642A (en) 2007-06-13
US20130245083A1 (en) 2013-09-19
AU2005221659A1 (en) 2005-09-22
EP1755559A1 (en) 2007-02-28
NZ588259A (en) 2012-09-28
DK2110124T3 (en) 2013-10-21
US20050276844A1 (en) 2005-12-15
EP2110124A1 (en) 2009-10-21

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